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COPDNCT05204888

myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home

A study testing myAirvo3 and Pulse oximeter in people with COPD, run by Temple University at 27 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Parallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade D, Stages II-IV patients with moderate to very severe COPD at risk for moderate… Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
COPD
What is being tested?
myAirvo3 and Pulse oximeter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
642 participants
Where
27 sitesin 2 countries
Study dates
2 Feb 2022to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Current self-reported chronic use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
  • A STOPBang Questionnaire score > 5*
  • Pregnancy or lactation
  • Treatment with another investigational drug or other intervention within the previous 30 days
  • Life expectancy less than 12 months due to COPD or other comorbid condition.
Show all 11Show fewer
  • Recent upper airway surgery (within the previous month)
  • Recent head or neck trauma (within the previous month)
  • Inability to tolerate nasal prongs
  • Requirement of oxygen greater than 15 L/min
  • subjects with a STOPBang questionnaire score of > 5 may be eligible if a recent sleep study (within the previous 3 months) shows the absence of obstructive sleep apnea or the subject has, or is at risk of OSA, but refuses to use an OSA device and all other eligibility criteria are met.

Trial locations and contacts

27 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Gerard Criner, MD contact

215-707-8113

Gerard.Criner@tuhs.temple.edu

Stephanie Yerkes contact

215-707-2357

stephanie.yerkes@temple.edu

27 sites in 2 countries

United States25 sites, 25 recruiting

  • University of Maryland - Baltimore

    Baltimore, Maryland, 21201

    Valeriay Rodionova, MD, 410-328-2835, vrodionova@som.umaryland.edu

    Jennifer So, MD

    Recruiting

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18102

    Monica Hosler, 484-658-4567, Monica.Hosler@sluhn.org

    Joseph Ramzy, MD

    Recruiting

  • UAB School of Medicine/Lung Health Center

    Birmingham, Alabama, 35205

    Cara Porter, RN, 205-975-4440, ceporter@uabmc.edu

    Mark Dransfield, MD

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Tumim Yifru, 617-636-6306, Tumim.Yifru@tuftsmedicine.org

    Nicholas Hill, MD

    Recruiting

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

    Jessica Curran, MSN, 781-744-8480, Jessica.Curran@Lahey.org

    Victor Pinto-Plata, MD

    Recruiting

  • The University of Vermont Medical Center, Inc

    Burlington, Vermont, 05401

    Olivia Johnson, 802-847-2160, Olivia.Johnson@uvmhealth.org

    Sophie Mancer, Sophie.Macner@uvmhealth.org

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Sara Smith, 773-702-4012, sara.smith@bsd.uchicago.edu

    Alejandra C Lastra, MD

    Recruiting

  • Cincinnati VA Medical Center

    Cincinnati, Ohio, 45220

    Christie Savickas, BSN/RN, 513-861-3100 ext. 205519, Christine.Savickas@va.gov

    Robert Burkes, MD

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Erica Corrao, RRT, MS, 216 444-0843, CORRAOE2@ccf.org

    Vickram Tejwani, MD

    Recruiting

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Janice Drake, 614-366-2186, Janice.Drake@osumc.edu

    Philip Diaz, MD

    Recruiting

  • Henry Ford Health

    Detroit, Michigan, 48202

    Zainab A Bhura, MBBS, 313-524-4147

    Jovica Veljanovski, MD

    Recruiting

  • Clinical Research Associates of Central Pennsylvania

    DuBois, Pennsylvania, 15801

    Dawn Jeanneart, 814-940-1212, djeannerat@lunginnovations.com

    Sandeep Bansal, MD

    Recruiting

  • Respire Research Institute

    Houston, Texas, 77094

    Motahar Qaadri, 346-396-1217 ext. 1085, mqaadri@ccriresearch.com

    Murtuza Ahmed, MD

    Recruiting

  • University of Florida, Jacksonville

    Jacksonville, Florida, 32209

    Ashleigh Trapuzzano, PT, DPT, 904-244-9633, Ashleigh.Trapuzzano@jax.ufl.edu

    Mehdi Mirsaeidi, MD, MPH

    Recruiting

  • Alloy Clinical Research

    Kissimmee, Florida, 34741

    David Conrado, 866-870-0148, dconrado@acrsite.net

    Linda M Martinez, MD

    Recruiting

  • Reliable Research, Inc.

    Miami, Florida, 33175

    Adonis Batista, (786) 953-6610, adonis.batista@research305.com

    David Orta, MD

    Recruiting

  • NewGen Health Group

    Miami, Florida, 33176

    305-892-1035

    Andrew Pastewski, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Catherine Larson, BS/RRT, 612-625-2153, sund0033@umn.edu

    Brooke Noren, RN, 612-625-7995, boer0039@umn.edu

    Recruiting

  • West Virginia Clinical and Translational Science Institute

    Morgantown, West Virginia, 26506

    Cami Handlan, RN, 304 293-6360, cami.handlan@hsc.wvu.edu

    Rachel Leonard, MD

    Recruiting

  • Destiny Research

    Palmetto Bay, Florida, 33157

    Iradis D Leal, 786.942.7912, iradis.leal@integrawellness.info

    Carlos Martinez, MD

    Recruiting

  • Jeanes Hospital

    Philadelphia, Pennsylvania, 19111

    Andrew Gangemi, MD

    Recruiting

  • Temple University

    Philadelphia, Pennsylvania, 19140

    Lii-Yoong Criner, RN, 215-707-9847, Lii-Yoong.Criner@tuhs.temple.edu

    Sheril George, BS, RRT, 215-707-1359, Sheril.George@tuhs.temple.edu

    Recruiting

  • The University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260

    Tiffany Ditter, 412-648-6276, dittertl2@upmc.edu

    Frank Sciurba, MD

    Recruiting

  • Honor Health

    Scottsdale, Arizona, 85258

    Mei Yu, 480-323-1292, myu@honorhealth.com

    Rick Sue, MD

    Recruiting

  • The Iowa Clinic

    West Des Moines, Iowa, 50266

    Natasha Mairs, RN, BSN, 515-875-9825, natasha.mairs@avacare.com

    Matthew Trump, DO

    Recruiting

Other trials in United States

Canada2 sites, 2 recruiting

  • The Research Institute of McGill University Health Centre

    Montreal, Quebec City, H3H 2R9

    Francine Noel, 514-934-1934 ext. 76213, francine.noel@muhc.mcgill.ca

    Marta Kaminska, MD

    Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

    Kathy Vandemheen, (613) 737-8259, kvandemheen@ohri.ca

    Shawn Aaron, MD

    Recruiting

Other trials in Canada

About this study

Official title: myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home - a Multi-center Randomized Controlled Trial

Parallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade D, Stages II-IV patients with moderate to very severe COPD at risk for moderate and severe exacerbations with a prior history of severe exacerbation requiring hospitalization within the past 6 weeks.

Read the detailed description

Objectives:

Primary Objective: To determine if HFNT delivered by myAirvo 3 increases the time to first moderate exacerbation orsevere exacerbation or all-cause mortality in patients with moderate to very severe COPD

Secondary Objectives:

To determine if HFNT delivered by myAirvo 3

  1. increases the time to first severe exacerbation
  2. increases the time to first exacerbation (moderate or severe)
  3. reduces severe exacerbation frequency
  4. reduces moderate and severe exacerbation frequency
  5. reduces hospitalization duration
  6. improves quality of life
  7. reduces dyspnea
  8. reduces PCO2
  9. is safe and well tolerated
  10. determine if any of the objectives are related to duration of daily HFNT use
  11. Assess cost effectiveness of HFNT use

Exploratory objectives:

Develop objective definitions of exacerbations of differing levels of severity based on myAirvo 3 device or electronic diary collected measures of heart rate, respiratory rate, oxygen saturation, and dyspnea measured by modified visual analog score.

Endpoints: Primary Endpoint: The time to first moderate or severe exacerbation or all-cause mortality.

Primary Safety Endpoint: All data on adverse events, including reported to be not, possibly, probably, or definitely related to the use of myAirvo 3 device.

Secondary Endpoints:

  • Rate of severe exacerbation, rate of moderate and severe exacerbations,
  • Time to moderate exacerbation, time to severe exacerbation, time to moderate or severe exacerbation
  • Hospitalization durations, from per visit data
  • Quality of life by St George's Respiratory Questionnaire and SF-12
  • Dyspnea, calculated mMRC and TDI over time
  • Hours of daily HFNT use
  • Impact of hours of daily HFNT use on any outcome
  • PCO2
  • Assess patient phenotype most likely to benefit from HFNT.
  • Assess cost effectiveness of HFNT use

Exploratory endpoints:

  • Development of objective definitions of exacerbations of differing levels of severity based on myAirvo 3 device or electronic diary collected measures of heart rate, respiratory rate, oxygen saturation, and dyspnea measured by modified visual analog score.
  • HFNT settings (flow rate and temperature)
Conditions
COPD
Being tested
myAirvo3, Pulse oximeter
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • myAirvo3Device

    For patients assigned to the HFNT intervention group, a myAirvo 3 device will be provided. The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 - 60 L/min depending on the patient interface. The myAirvo 3 is for patients in homes and long-term care facilities.

  • Pulse oximeterDevice

    A pulse oximeter will be provided to measure heart rate and pulse oximetry; subjects will enter and transmit the data on the smartphone once daily before 11AM. Heart rate and pulse oximetry measures will be taken after wearing the device for approximately 2 minutes.

Study groups in NCT05204888
Study groupRoleWhat they receive
Usual COPD careActive comparatorThe intervention : A pulse oximeter to record heart rate and pulse oximetry on a daily basis will be provided. A smart phone and charger will also be provided to answer a short questionnaire that queries daily respiratory symptoms plus enter heart rate and pulse oximetry data
Receives: Device: Pulse oximeter
Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator.Active comparatorThe intervention is the myAirvo 3 humidifier with integrated flow generator delivered through the Optiflow™ + Duet nasal cannula.
Receives: Device: myAirvo3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine if myAirvo 3 use increases the time to first moderate exacerbation/severe exacerbation (hospitalization)/all-cause mortality in patients with moderate to very severe COPD.

    Time to first moderate or severe COPD exacerbation

    Measured: 1 year

Secondary outcomes (14)

  1. Time to first severe exacerbation

    To determine if HFNT delivered by myAirvo 3 increases the time to first severe exacerbation

    Measured: 1 year

  2. Time to moderate or severe exacerbation

    To determine if HFNT delivered by myAirvo 3 increases the time to first exacerbation (moderate or severe)

    Measured: 1 year

  3. Severe exacerbation frequency

    To determine if HFNT delivered by myAirvo 3 reduces severe exacerbation frequency

    Measured: 1 year

  4. Moderate/severe exacerbation frequency

    To determine if HFNT delivered by myAirvo reduces moderate and severe exacerbation frequency

    Measured: 1 year

  5. Hospital length of stay

    To determine if HFNT delivered by myAirvo 3 reduces hospitalization duration

    Measured: 1 year

  6. Quality of life - SF-12 questionnaire

    To determine if HFNT delivered by myAirvo improves quality of life as measured by the SF-12

    Measured: 1 year

  7. Quality of life - Severe Respiratory Insufficiency Questionnaire

    To determine if HFNT delivered by myAirvo improves quality of life as measured by the Severe Respiratory Insufficiency Questionnaire

    Measured: 1 year

  8. Quality of life - Saint George's Respiratory Questionnaire

    To determine if HFNT delivered by myAirvo improves quality of life as measured by the Saint George's Respiratory Questionnaire

    Measured: 1 year

  9. Quality of life - Baseline Dyspnea Index and Transitional Dyspnea Index

    To determine if HFNT delivered by myAirvo improves quality of life as measured by the EQ-5D questionnaire

    Measured: 1 year

  10. Dyspnea

    To determine if HFNT delivered by myAirvo reduces dyspnea as measured by the Baseline Dyspnea Index and Transitional Dyspnea Index

    Measured: 1 year

  11. pCO2 reduction

    To determine if HFNT delivered by myAirvo reduces pCO2

    Measured: 1 year

  12. Adverse event reporting

    To determine if HFNT delivered by myAirvo is safe and well tolerated

    Measured: 1 year

  13. Correlations with average hours of use

    To determine if any of the above outcomes are related to duration of daily HFNT use

    Measured: 1 year

  14. Cost effectiveness

    To assess the cost effectiveness of HFNT use in COPD

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start2 Feb 2022
  3. Primary completionJan 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients assigned to the HFNT group will be provided a myAirvo 3 device. The myAirvo 3 is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces. The interface used in this trial is the Optiflow™ + Duet nasal cannula sized for patient comfort. Patients will also be provided with a pulse oximetry device that connects to the myAirvo 3 to record pulse oximetry and heart rate once daily after wearing the device for two minutes. Patients assigned to the control group will be provided with a pulse oximetry device to record pulse oximetry and heart rate once daily after using the pulse oximeter for two minutes as well as answering a respiratory questionnaire and input data into a smartphone adapted to be used as an electronic diary.
Masking
None (open label)
Enrolment
642 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05204888
Sponsor's protocol ID
268447
Status last verified
Jan 2025
First submitted
20 Dec 2021
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing myAirvo3 and Pulse oximeter in people with COPD, run by Temple University at 27 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gerard Criner, MD (215-707-8113, Gerard.Criner@tuhs.temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine if myAirvo 3 use increases the time to first moderate exacerbation/severe exacerbation (hospitalization)/all-cause mortality in patients with moderate to very severe COPD. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05204888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.

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